DAVID H. GARABRANT, P.L.L.C. 3063 GEDDES AVENUE
ANN ARBOR, MICHIGAN 48104 ------
734-936-0753
DAVID H. GARABRANT, M.D., M.P.H.
Mr. Christopher D. Stofko Dickie, McCamey & Chilcote, P.C. Two PPG Place Suite 400 Pittsburgh, PA 15222-5402
June 10, 2010
RE: Christopher Scearce v. The Sherwin-Williams Company, et al.
Dear Mr. Stofko,
I am a licensed physician specializing in occupational medicine. I am board certified in both occupational medicine and internal medicine. I am qualified as a specialist in the fields of occupational medicine and internal medicine and in the field of epidemiology, especially as it relates to the study of diseases related to exposures to chemical agents. I am Emeritus Professor of Occupational Medicine and Epidemiology at the University of Michigan School of Public Health, and I also hold an appointment as Emeritus Associate Professor in the Department of Emergency Medicine, University of Michigan School of Medicine. I am engaged full-time in research in occupational epidemiology, the training and education of physicians and graduate students in occupational health, and in the clinical practice of occupational medicine.
I received my undergraduate degree with high honors in chemical engineering from Tufts University, Medford, Massachusetts in 1972. I received my M.D. degree from Tufts University School of Medicine, Boston, in 1976. From 1976-77, I served as an intern in internal medicine at Georgetown University Hospital in Washington, D.C. and from 1977-78, I served as a fellow in medical ambulatory care at that same institution. From 1978-80, I served as a resident in occupational medicine at the Harvard School of Public Health, Boston, and received the Master of Public Health degree in 1979 and the Master of Science in Physiology degree in 1980 from that institution. From 1980-81, I served as senior resident in internal medicine at University Hospital, Boston.
Upon completion of my training in 1981, I joined the faculty of the University of Southern California School of Medicine, where I was engaged in research in occupational cancer epidemiology and in the practice of occupational medicine until 1988, when I joined the faculty of the University of Michigan. While I have been on the faculty of the University of Michigan, I have served as Director of Occupational Medicine (1988-94), head of the Occupational Health Program (1992-95), Director of the Center for Occupational Health and Safety Engineering
(1990-95), Director of the Occupational & Environmental Epidemiology program (2001-2007), and Founding Director of the Risk Science Center (2003-present). My research has focused for the past 25 years on the long term health effects of chemicals on humans and I have published over 200 research articles, book chapters, and abstracts related to this area. A copy of my curriculum vitae is attached.
I have served on the Editorial Board of the Journal of Occupational Medicine and currently serve as a reviewer of scientific papers for a number of other journals, including Environmental Health Perspectives, Journal of the National Cancer Institute, Cancer Causes and Control, Cancer Epidemiology Biomarkers and Prevention, American Journal of Epidemiology, and Cancer Research. I was appointed to membership on the Safety and Occupational Health Study Section of the National Institutes of Health (NIH) in 1992 and served on that Study Section until 1996, having been appointed by Secretary of HHS Donna Shalala as Chair for the 1995-96 year. In that position I served as a peer-reviewer of research proposals for the NIH. I am a Fellow of the American College of Occupational and Environmental Medicine (FACOEM) and a Fellow the American College of Preventive Medicine (FACPM). I am currently a member of a number of professional organizations, including the Society for Epidemiologic Research, the International Epidemiological Association, the Society for Risk Analysis, and the American College of Occupational and Environmental Medicine. I received the Excellence in Research Award from the University of Michigan School of Public Health in 2006 and the Research Excellence Award from the Risk Science Center at the University of Michigan School of Public Health in 2007.
Materials Reviewed I have reviewed the materials that your office forwarded to me including:
Complaint Plaintiffs' Answers to Defendant Sherwin-Williams Company's First Set of
Interrogatories to Plaintiffs Plaintiffs' Responses to Sherwin-Williams' First Set of Request for Production of
Documents and Things Sherwin-Williams Toluene MSDS Sherwin-Williams Specification for Purchased Material; Material: Toluene; Supplier:
Ashland Distribution Co.; Revision Date: 11/09/1995 Customer Certificates of Analysis from Ashland Distribution Company to Sherwin-
Williams (2003-2005) Plaintiffs'Expert Witness Disclosure Expert Reports, Evaluations and Records
- Expert report of Peter Infante, Dr.P.H. dated 4/27/10 - Declaration of Martyn T. Smith, Ph.D. dated 4/27/09 - Report of Nachman Brautbar, M.D. dated 4/28/10 - Report of J.C. Poindexter, Ph.D. dated 7/5/09 - Report of Noel deNevers, Ph.D. (not dated) - Report of Stephen E. Petty, P.E., C.I.H. dated 4/26/10 - Curriculum Vitae of David Hurd, M.D.
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- Report of David Pyatt, Ph.D., dated 5/31/10 - Report of Bernard Goldstein, M.D., dated 5/28/10 - Report of Bradford Russell, MS, CIH,CPEA, dated 6/1/10 Photographs of the Entwistle Company plant in Danville, VA Sherwin Williams specifications for toluene Sherwin Williams Material Safety Data Sheet for solvents, dated 1/21/02 and 10/15/04 Sherwin Williams Industrial and Marine Coatings Product Information for Solvents Entwistle personnel file for Christopher Scearce Various OSHA inspection reports and corrective actions, OSHA Form 300A, plant diagrams, toluene air monitoring reports, various MSDSs Depositions - Christopher Scearce (with exhibits), taken 1/13/09, 5/12/09, 7/2/09 - Angela Scearce (with exhibits), taken 1/28/09, 5/12/09 - Michael Scott Liverman, taken 7/1/09 - Barry Scott, taken 7/1/09 - Kenneth Duffy, taken 7/8/09 - Donald C. Price, Jr., taken 4/23/10 - Randy L. Gibson, taken 4/23/10 Medical Records - Piedmont Primecare of Danville - Annie Penn Hospital - Wake Forest University Baptist Medical Center
In addition, I have reviewed the scientific literature that is relevant to the issues of causation of acute myelogenous leukemia. A list of the relevant scientific literature upon which my opinions are based, is attached.
Past Medical History Mr. Christopher Scearce was born on 3/2/1973. He smoked between one half and one
pack of cigarettes a day between 1996 and 2006. His mother smoked in the house while he was growing up and his first wife (1998-2001) smoked in the house while they were together. He has no significant past medical history and there is no history of lymphohematopoetic cancer in his family.
Occupational History A summary of Mr. Scearce's occupational history and alleged exposure to benzene and
benzene-containing chemicals is given below.
Employer
Rally's Hamburgers Danville, VA
Bogie's Danville, VA
Service Linen Co. Danville, VA
Dates Employed 1990-1992
1992-1995
1995
Job Title/Duties
Cook; clean grill, dishes, mop floor
Cook; clean grill, dishes, mop floor
Loaded laundry bins; only clean uniforms
Alleged Exposure(s) None
None
None
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Employer
Durham Hosiery Danville, VA
Carolina Hosiery Burlington, NC
Dodson Snacks Sales, Inc. Ringgold, VA
Wise Chips Danville, VA
Debbie's Staffing/Entwistle Danville, VA
Chemtek, Inc. Yanceyville, NC
Dates Employed 1995-1998 1998-1999 1999-2000
2000-2001 2002-2005
Job Title/Duties
Fixed industrial size sewing machines
Fixed industrial size sewing machines
Delivery driver, filled his own truck at a local station
Delivery driver, filled his own truck
Assembler; assembled parts on JDAM bombs
Alleged Exposure(s) 3-IN-ONE oil (machine lubricant) 3-IN-ONE oil (machine lubricant) Gasoline
Gasoline
Toluene, glue
2005-2006
Maintenance mechanic
Parts washer (mineral spirits), Pave Rx
Mr. Scearce worked for Dodson Snacks Sales/Tom's Vending from 1999 to 2000. In the complaint it is alleged that "during his employment with Tom's Vending, he purchased and selffilled approximately forty-five (45) gallons of benzene-containing gasoline from the Hutchenssupplied River Street Sun service station daily."
From 2000 to 2001, Mr. Scearce worked at Wise Chips. In the complaint it is alleged that "during his employment with Wise Potato Chips he purchased and self-filled approximately forty-five (45) gallons of benzene containing gasoline from Abercrombie's Pacific Pride facility, located at 1385 S. Boston Road facility in Danville, Virginia once or twice a day."
In March 2002, Mr. Scearce started working for Entwistle as a temporary worker and in May he was hired on full-time as an Entwistle employee. He worked on the Joint Direct Attack Munition (JDAM) line. His first job was pressing basket nuts into an aft and did not require solvent use although he was in the proximity of others using toluene. After a few months, Mr. Scearce moved to work with the heli-coil rings and remained there until he left Entwistle in May 2005.
It is alleged that Mr. Scearce was directly exposed to benzene-containing toluene while he was working with the heli-coil rings. The sequence of his job tasks on this part of the assembly line was as follows: blow excess water off of the ring with compressed air, inspect ring for leftover metal shavings, lay ring flat on table, install glue around the first few threads of each of eight holes, take the drill with special heli-coil installer attachment and install eight heli-coils, break off the installation tab on each heli-coil, dip a rag into toluene container, wash the ring with toluene front and back making sure there is no glue or oil left on the ring.
The toluene used for cleaning the rings was kept in a 2-quart plunger can within arm's reach of Mr. Scearce. Mr. Scearce said he would dampen the rag with toluene and then wring it out before using it on the ring. He laid the ring on his desk in order to clean the holes and then in his lap in order to clean the outside. It is alleged that he got toluene on his hands, wrists, thighs,
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and forearms during this process. It is also alleged that he breathed toluene vapors during his entire shift. Mr. Scearce went through about 1500-1700 heli-coils a day, or about 200 rings. Each ring was either 18 or 22 inches in diameter.
Mr. Scearce was also responsible for refilling the 2-quart plunger can when it was empty. He said he washed the can out and refilled it every couple hours from the five gallon bucket of bulk toluene. Mr. Michael Scott Liverman, who worked with the heli-coils before Mr. Scearce did, and was responsible for training him, stated in his deposition that he personally never used more than one plunger can during a work shift.
Mr. Scearce's uniform at Entwistle consisted of a short-sleeve shirt and pants, or shorts in the summer. He always wore safety goggles but said that he was unable to wear gloves because of his inability to maintain the necessary production rate with them on. He claims that, because of this, his hands became very callused and cracked over time. Mr. Scearce also stated in his deposition that he began to get frequent headaches after he moved to the heli-coil ring assembly job.
Both of Mr. Scearce's jobs were located in one section of a three section A-frame warehouse building. His section was on one end of the building and was approximately 100 yards long and 20 yards wide. The roof slanted up toward the middle of the building with the highest point being about 40 feet and the lowest point being 15 feet. There was a large garage door about 40 yards from his work station that was open when weather permitted and two emergency doors that remained closed. Mr. Scearce recalls there being two 30-40 inch diameter portable fans on six-foot stands on his line. The production supervisor for the line, Mr. Donald Price, stated in his deposition that these fans were positioned to blow chemicals away from Mr. Scearce.
It is alleged in the Answers to Interrogatories that
"...Sherwin-Williams' toluene contained somewhere between 0.03%, 0.05%, 1.025% (the range average amount) or 2.0% benzene. Mr. Scearce's inhalation exposure to benzene from Sherwin-Williams toluene ranges approximately from a low of 5 parts per million years (based on 0.03% benzene in the toluene) to a high of 31 parts per million years (based on 2.0% benzene in the toluene), with the average amounting to 15.7 ppm years (based on 1.025% benzene in the toluene). Mr. Scearce's dermal exposure to benzene from Sherwin-Williams toluene ranges approximately from a low of 18 parts per million years (based on 0.03% benzene in the toluene) to a high of 104 parts per million years (based on 2.0% benzene in the toluene), with the average amounting to 53.6 ppm years (based on 1.025% benzene in the toluene). Mr. Scearce's total benzene exposure from working with Sherwin-Williams' toluene ranges from 23 ppm years to 135 ppm years with the average amounting to 69.3 ppm years."
Sherwin-Williams specifications for the toluene supplied by Ashland Distribution Co. dictated a maximum limit of 0.03 percent by volume benzene.
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In May 2005, Mr. Scearce left Entwistle and started working at Chemtek, Inc. as a maintenance man and diesel mechanic. Mr. Scearce stated that his job duty as a maintenance man was to perform all in-house maintenance including wiring, repairing, and replacing pipes and pumps. As a diesel mechanic he maintained and repaired all of the equipment and road tractors used to haul equipment. He estimated he spent 80% of his time doing maintenance work with the remainder doing diesel mechanic work.
As a maintenance man, Mr. Scearce was required to be on site when Chemtek's PaveRX rejuvenator product was manufactured. This occurred 10-12 times during Mr. Scearce's employment and the days were eight to over twelve hours long. Mr. Scearce said that often there were problems with the equipment during this process and he had to be available to make necessary repairs. The most severe incident was when a hose split and spewed black tar on everyone, including Mr. Scearce. He stated that normally though, the incidents were that a pipe clamp was loose and needed to be replaced, a valve was leaking and needed to be tightened, a pipe was leaking and needed to be replaced, or a mixer needed to be greased.
Mr. Scearce said he wore latex gloves while working with PaveRX, but they constantly broke down or split while working with the product. He said the product was all over everything and he got it all over himself just by handling the hoses and working with tools. He claimed it went right through his clothes and often he would find "tiger stripes" on his legs from the tar after he got home and undressed.
As part of his job, Mr. Scearce also used a parts washer for 1.5 to 2.0 hours daily. The parts washer contained mineral spirits and had a spray nozzle with a brush. Mr. Scearce used the washer to clean tools and equipment parts. He said he used dishwashing-type gloves that came up his forearms while using the washer.
Present Illness Mr. Scearce presented to Piedmont PrimeCare on 9/3/06 complaining of fever (over the
previous four days), headache, abdominal pains, sweats, chills, fatigue, sore throat, loss of appetite, and body aches. He was treated with an antibiotic and encouraged to go to the ER if he did not improve. Mr. Scearce's fever persisted and he started having difficulty breathing. On 9/6/06, he presented to Annie Penn Hospital where he was diagnosed with acute myelomonocytic leukemia.
Mr. Scearce was transferred to Wake Forest University Baptist Medical Center for treatment and care. Bone marrow biopsy and aspiration were performed on 9/7/06, confirming a diagnosis of acute myelomonocytic leukemia FAB M4, with t(16;16). A summary of the bone marrow report and corresponding cytogenetics is given below.
Procedure Date Final Pathologic Diagnosis
Bone marrow aspiration and biopsy
9/7/2006
Acute myelomonocytic leukemia Comment: The blasts have abundant cytoplasm, and some demonstrate vacuoles. A myeloid phenotype is seen by flow cytometry, and a
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Flow Cytometry Cytogenetics
significant monocytic component is present. Blasts are myeloperoxidase positive and approximately 20% are positive for Butyrate esterase positive. PAS stain is negative. Rare eosinophils have dysplastic granules raising the possibility of an inverse 16 chromosomal abnormality.
Results-Comments: A large monocytic component is present, and blast gate demonstrates myeloid phenotype, consistent with acute myelomonocytic leukemia.
Interpretation: 46,XY,t(16;16)((p13.1q22)[20] .ish t(16;16)(p13q22)(spCBFG)
Cytogenetic Analysis: Abnormal: Cytogenetic analysis revealed the presence of a cytogenetically abnormal with an apparent translocation 16;16. The t(16;16) is a variant of the inv(16) and is associated with AML-M4E0 and a good prognosis.
Molecular Cytogenetic Analysis FISH: Abnormal: The investigative technique of molecular cytogenetic analysis with a DNA probe specific for the CBFG gene region of 16q22 revealed that a significant number of cells (92.5%) had one chromosome 16 demonstrating a split of the CBFG gene. Thus, the gene is now located on the long and short arm of chromosome 16. This finding is consistent with an inversion of chromosome 16 and the t(16;16).
Mr. Scearce underwent induction chemotherapy with standard dose araC/Daunorubicin/VP-16 "7+3+3". His day 14 bone marrow biopsy and aspirate were performed on 9/21/06. Cellularity was low and most cells were lymphocytes. A slight increase in connective tissue with accompanying stromal cells was noted in the biopsy. No residual leukemia was observed. Follow-up bone marrow biopsy and aspiration were performed on 10/10/06 and pathology, cytogenetics, and FISH were all consistent with remission. Mr. Scearce underwent three courses of high dose ara-C consolidation therapy from between October 2006 and January 2007.
A bone marrow biopsy and aspiration were performed on 3/9/07, and showed a slightly elevated blast fraction (6%). Eosinophils were also elevated (7%) and some precursor cells exhibiting abnormal cytoplasmic granulation were noted. The results were worrisome for minimal residual leukemia. FISH analysis revealed that 1.5% of cells had one chromosome 16 demonstrating a split of the CBFB gene. This percentage of cells was borderline abnormal.
Mr. Scearce appeared to do well until 7/18/07, when he presented complaining of an episode of bilateral hand, lower leg and foot numbness. There was concern for CNS involvement of his leukemia. A bone marrow aspirate and biopsy was performed on 7/24/07 and showed normocellular marrow with borderline elevated eosinophils and blast fraction. FISH analysis for t(16;16) revealed an increase (12%) in the number of cells with one chromosome 16 demonstrating a split of the CBFB gene. The findings were consistent with early relapse. Cerebrospinal fluid was negative for malignancy.
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Mr. Scearce underwent reinduction with high dose ara-C and Etoposide from 8/8 to 8/13/07 and also began the process of being worked up for an allogeneic bone marrow transplant. Bone marrow biopsy and aspiration were performed on 9/19/07. Blasts were in the normal range but dysplastic eosinophils were present, again suspicious for early relapse. Cytogenetic analysis and FISH were normal.
Mr. Scearce underwent matched unrelated donor peripheral blood stem cell reinfusion on 10/10/07. As of September 2009, Mr. Scearce's counts were stable and he had no evidence of recurrent disease. He suffers from chronic graft versus host disease and is on immunosuppressive therapy.
My Opinions
1. Mr. Christopher Scearce was diagnosed with acute myelomonocytic leukemia (FAB M-4) with t(16:16) in September 2006 at age 33. He was treated for this disease and is currently in remission.
2. AML has been causally associated with cumulative benzene exposures above 40-200 ppm-years (Adegoke, 2003; Australian Institute of Petroleum, 2007; Bond, 1986; Glass, 2003; Glass, 2006; Gray, 2001; Guenel, 2002; Hayes, 1997; Paxton, 1994a; Paxton, 1994b; Rinsky, 1987; Rushton, 1997; Schnatter, 1996a; Schnatter, 1996b; Schnatter, 2004). There are numerous studies of humans exposed to benzene at cumulative exposures below 40 ppm-yrs that show no increased risk of AML. The epidemiologic literature, when analyzed properly and when including all relevant studies, does not support a conclusion that benzene exposures below 40 ppm-yrs place people at increased risk of AML.
3. It is my understanding from the report of Bradford Russell that Mr. Scearce's cumulative exposure to benzene while he worked at the Entwistle Company in 20022005 was approximately 0.018 ppm-years and the concentration of benzene in the air was 0.0065 ppm. There is no scientific evidence that either cumulative exposure to benzene at 0.018 ppm-years, or exposure to benzene at 0.0065 ppm is associated with increased risk of AML in general, or increased risk of AML-M4 specifically. There is no scientific basis for a claim that benzene exposure at this low level causes AML or AML-M4 specifically.
4. Toluene is not known to cause cancer in humans or in animals (IARC, 1999). There is no reliable evidence that toluene exposure is associated with increased risk of AML or of AML-M4. There have been a substantial number of epidemiological studies that have looked at risks of leukemia specifically among toluene-exposed worker and which have shown no consistent evidence of increased risk of AML or AML-M4 (IARC 1999; Blair, 1998; Svensson, 1990; Wiebelt, 1999; Lehman, 2006; Walker, 1993; Costantini, 2008; Adegoke, 2003; Wong, 2009).
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5. Mr. Scearce smoked between one half and one pack of cigarettes a day between 1996 and 2006. Smoking is an established cause of AML (Brown, 1992; Brownson, 1993; Kasim, 2005; Kinlen, 1998; Linet, 2006; Linet, 1991; Mills, 1990; Petridou, 2008; Pogoda, 2002; Sandler, 1993; Thomas, 2004), and is strongly associated with AMLM4 (Pogoda,2002)(Crane et al. 1989). The role of smoking in Mr. Scearce's AML cannot be ruled out.
It is my opinion to a reasonable degree of medical certainty that there is no scientific basis for a conclusion that exposures to toluene or the small amount of benzene that might have been present in toluene which Mr. Scearce handled while he was employed at Entwistle Company in 2002-2005 played any role whatsoever in the causation of his acute myelomonocytic leukemia.
David H. Garabrant, MD, MPH Emeritus Professor of Occupational Medicine and Epidemiology The University of Michigan
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